HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

12788 N

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN 1

BESLUIT

Op 27 september 2007 is van Diversey B.V. Maarssenbroeksedijk 2 3542 DN UTRECHT

een aanvraag verlenging toelating biocide ontvangen voor het middel Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) op basis van de werkzame stof salicylzuur. HET COLLEGE BESLUIT tot verlenging van bovenstaand middel. Alle bijlagen vormen een onlosmakelijk onderdeel van dit besluit. Voor nadere gegevens over deze toelating wordt verwezen naar de bijlagen: - Bijlage I voor details van de aanvraag en toelating; - Bijlage II voor de etikettering; - Bijlage III voor wettelijk gebruik; - Bijlage IV voor de onderbouwing. 1.1

Samenstelling, vorm en verpakking

De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend. 1.2

Gebruik

Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage III bij dit besluit is voorgeschreven. 1.3

Classificatie en etikettering

Mede gelet op de onder “wettelijke grondslag” vermelde wetsartikelen, dienen alle volgende aanduidingen en vermeldingen op de verpakking te worden vermeld: 

De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder “verpakkingsinformatie” in bijlage I.

Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic), 20070984 TVB

1

12788 N  Het toelatingsnummer.  Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in bijlage III, onder A.  De gebruiksaanwijzing, hetzij letterlijk, hetzij naar zakelijke inhoud, zoals opgenomen in bijlage III, onder B. De tekst mag worden aangevuld met technische aanwijzingen voor een goede bestrijding mits deze niet met die tekst in strijd zijn.  Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen. 2

WETTELIJKE GRONDSLAG

Besluit

Classificatie en etikettering Gebruikt toetsingskader 3

artikel 122 (alleen als de aanvraag in 2007 is ingediend), artikel 121, eerste lid, de juncto artikel 66, eerste lid, Wet gewasbeschermingsmiddelen en biociden artikel 89, tweede lid, Verordening 528/2012, jo. artikel 130a, vierde lid, WBB, jo. artikel 50 WGB oud RGB (Hoofdstuk 10)

BEOORDELINGEN

3.1 Fysische en chemische eigenschappen De aard en de hoeveelheid van de werkzame stoffen en de in humaan-toxicologisch en ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn bepaald. De identiteit van het middel is vastgesteld. De fysische en chemische eigenschappen van het middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar geacht. 3.2 Analysemethoden De geleverde analysemethoden voldoen aan de vereisten om de residuen te kunnen bepalen die vanuit humaan-toxicologisch en ecotoxicologisch oogpunt van belang zijn, volgend uit geoorloofd gebruik. 3.3 Risico voor de mens Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor de mens verwacht. 3.4 Risico voor het milieu Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor het milieu verwacht. 3.5 Werkzaamheid Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften verwacht dat het werkzaam is.


2

12788 N Bezwaarmogelijkheid Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 4 van Bijlage 2 bij de Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 8030, 6710 AA, EDE. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld.

Ede, 6 november 2015 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN,

Ir. J.F. de Leeuw Voorzitter


3

12788 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING 1 Aanvraaginformatie Aanvraagnummer: Type aanvraag: Middelnaam: Verzenddatum aanvraag: Formele registratiedatum: * Datum in behandeling name:

20070984 TVB aanvraag verlenging toelating biocide Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) 21 september 2007 27 september 2007 31 maart 2015

* Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan. 2 Stofinformatie Werkzame stof salicylzuur

Gehalte 15%

De werkzame stof salicylzuur is opgenomen in het reviewprogramma maar nog niet geplaatst op de Unielijst van Goedgekeurde Werkzame stoffen volgens Verordening 528/2012. 3 Toelatingsinformatie Toelatingsnummer: 12788 N Expiratiedatum: * Afgeleide of parallel: n.v.t. Biocide, gewasbeschermingsmiddel of Biocide toevoegingsstof: Gebruikers: Professioneel * De toelating geldt tot het tijdstip waarop de lidstaten maatregelen genomen hebben om de nationale toelating in overeenstemming te brengen met het besluit over de werkzame stof van de Europese Commissie. 4

Verpakkingsinformatie

Aard van het preparaat: Met water mengbaar concentraat


1

12788 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II Etikettering van het middel Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic)

Diverflow VB19 (Alpha): Professioneel gebruik de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel: Pictogram: Signaalwoord Gevarenaanduidingen

Voorzorgsmaatregelen

GHS07 WAARSCHUWING H290 Kan bijtend zijn voor metalen. H315 Veroorzaakt huidirritatie. H319 Veroorzaakt ernstige oogirritatie. P280 Beschermende handschoenen/beschermende kleding/oogbescherming/gelaatsbescherming dragen.

Aanvullende etiketelementen Kinderveilige sluiting verplicht Voelbare gevaarsaanduiding verplicht

Nee Nee

Diverflow VA8 (Basic): Professioneel gebruik de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel: zwavelzuur Pictogram GHS05 Signaalwoord GEVAAR Gevarenaanduidingen H290 Kan bijtend zijn voor metalen. H314 Veroorzaakt ernstige brandwonden en oogletsel. Voorzorgsmaatregelen P260 Stof/rook/gas/nevel/damp/spuitnevel niet inademen. P280 Beschermende handschoenen/beschermende kleding/oogbescherming/gelaatsbescherming dragen. P303 + P361 + P353 BIJ CONTACT MET DE HUID (of het haar): verontreinigde kleding onmiddellijk uittrekken. Huid met water afspoelen/afdouchen. P305 + P351 + P338 BIJ CONTACT MET DE OGEN: voorzichtig afspoelen met water gedurende een aantal minuten; contactlenzen verwijderen, indien mogelijk. Blijven spoelen. P310 Onmiddellijk een ANTIGIFCENTRUM/arts/... raadplegen. Aanvullende etiketelementen Kinderveilige sluiting verplicht Nee Voelbare gevaarsaanduiding verplicht Nee


1

12788 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE III WG/GA van het middel Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) A. WETTELIJK GEBRUIKSVOORSCHRIFT Toegestaan is uitsluitend het gebruik als middel ter bestrijding van bacteriën (exclusief mycobacteriën en bacteriesporen), gisten en schimmels op oppervlakken in (fris)drankenindustrie, inclusief bierbrouwerijen, waar drinkwaren en grondstoffen hiervoor worden bereid, behandeld en bewaard. Het middel is niet toegestaan in melkwinningsapparatuur op de boerderij en keukens in instellingen voor gezondheidszorg. Gezien het feit dat het middel in twee componenten wordt aangeleverd dient het met de nodige zorg in de juiste volgorde en verdunningsgraad op de gebruiksplaats aangemaakt te worden. Het middel mag uitsluitend worden toegepast met daarvoor geschikte doseerapparatuur in gesloten proces-apparatuur. De toepasser dient de gebruiksaanwijzingen voor de doseerinstallatie van de leverancier te volgen. De gebruiksaanwijzing zoals opgenomen onder B. moet worden aangehouden. Het middel is uitsluitend bestemd voor professioneel gebruik.

B. GEBRUIKSAANWIJZING Algemeen Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) bestaat uit twee componenten, Diverflow VB19 (Alpha) (salicylzuur) en Diverflow VA8 (Basic) die uitsluitend in combinatie met elkaar gebruikt mogen worden. Dit middel wordt gebruikt voor het desinfecteren van tanks, leidingen, filtratie-apparaten, afvulmachines, vaten en tapinstallaties in de (fris)drankenindustrie inclusief bierbrouwerijen. Doorgaans maar niet uitsluitend wordt het middel toegepast als een één-staps reinigings- en desinfectiesysteem, bij lagere temperaturen, tot minimaal 4oC. De dosering: Diverflow VB 19 (Alpha) 0,25% (v/v) en Diverflow VA8 (Basic) 2% (v/v). Aanbevolen behandelingsduur (exclusief voor- en naspoeltijd) is 30 minuten, waarbij gebruik gemaakt wordt van een rondpomp systeem zoals gebruikelijk in een Cleaning in Place (CIP-installaties). Algemene werkwijze 1. De te reinigen en te desinfecteren oppervlakken worden vooraf gedurende 5 minuten gespoeld met schoon water. 2. De feitelijke reinigings- en desinfectiestap begint met het doorspoelen van de CIPinstallatie met het product waarbij de eerste 5%-10% (van de inhoud van de CIPinstallatie van het te reinigen object) wordt verwijderd naar de afvalwater behandeling. Dit percentage is afhankelijk van de bepaalde vervuilingsgraad. 3. Het overige product wordt rondgepompt in de CIP-installatie voor de resterende tijd.


1

12788 N 4. De behandelde oppervlakken worden vervolgens gedurende 5-10 minuten nagespoeld met schoon water. Er dient zolang nagespoeld te worden dat er geen salicylzuur meer aanwezig is in het spoelwater. Dit dient steekproefsgewijs te worden gecontroleerd. 5. Het middel blijft in opslag voor hergebruik waarbij uitsluitend het verloren gedeelte wordt aangevuld. Dosering van de gebruiksoplossing - Diverflow VB 19 (Alpha) dient te worden voorverdund (maximaal 10%) om kristallisatie te voorkomen. - Diverflow VA 8 (Basic) wordt tegelijkertijd of na Diverflow VB 19 (Alpha) toegevoegd met behulp van volautomatische doseerapparatuur. Hierbij dient de mogelijkheid te bestaan om beide componenten proportioneel toe te voegen. De dosering dient plaats te vinden met behulp van daarvoor geschikte meetapparatuur (bij voorkeur geleidbaarheidsmeter of flowmeter). - Tijdens de dosering dient turbulentie/menging aanwezig te zijn ter voorkoming van kristallisatie van ingrediënten.


2

Toelatingsnummer 12788 N

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE IV RISKMANAGEMENT

Contents Algemene werkwijze ............................................................................................................... 1 1 Introduction ...................................................................................................................... 4 2 Identity............................................................................................................................. 4 3 Physical and chemical properties ......................................................................................... 5 4 Analytical methods for detection and identification ............................................................... 7 5 Efficacy ............................................................................................................................. 8 6 Human toxicology .............................................................................................................. 8 7 Environment ................................................................................................................... 13 8 Conclusion ...................................................................................................................... 18 9 Classification and labelling ................................................................................................ 18 10 References .................................................................................................................. 20


3


1

Introduction

1.1 Applicant Diversey B.V. Maarssenbroeksedijk 2 3542 DN Utrecht 1.2 Active substance The active substance is salicylic acid. 1.3 Product Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) 1.4 Function Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) is a disinfectant (PT04). 1.5 Background to the application This concerns an Application for re-authorisation of an existing authorisation of a biocidal product. 1.6 Intended uses Dual CIP Diverflow VB19 (Alpha)/Diverflow VA8 (Basic) is a “Cleaning In Place” (CIP) product for the disinfection of surfaces in the soft drink industry and in breweries, excluding milking parlour systems on farms, and kitchens in health care facilities. 1.7 Packaging details Diverflow VB19 (Alpha): HDPE: 950L IBC, 200L, 20L Diverflow VA8 (Basic): only bulk transport 2

Identity

2.1 Identity of the active substance Common name Salicylic acid Name in Dutch Salicylzuur Chemical name 2-hydroxybenzoic acid (IUPAC) CAS no 69-72-7 EC no 200-712-3 (EINECS) The active substance salicylic acid is not included in the Union list of approved substances of EU Regulation 528/2012. A CAR is not available. NL is eCA. The list of endpoints below is taken from the IUCLID dossier. Active substance (ISO Common Name) Salicylic acid (common name) Chemical name (IUPAC)

2-hydroxybenzoic acid

Chemical name (CA)

2-hydroxybenzoic acid

CIPAC No

Not available

CAS No

69-72-7

EEC No (EINECS or ELINCS)

200-712-3

FAO Specification (including year of publication)

Not available


4


Minimum purity of the active substance as manufactured (g/kg)

> 99,5 %

Identity of relevant impurities (of toxicological, environmental and/or other significance) in the active substance as manufactured (g/kg)

No information, however the product is of pharmaceutical quality and information sheets of batch-analysis are available

Molecular formula

C7H6O3

Molecular mass

138.1

Structural formula

2.2 Identity of the biocidal product Name Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) Formulation type Diverflow VB19 (Alpha): SL Diverflow VA8 (Basic): SL Content active substance Diverflow VB19 (Alpha): Salicylic acid: 15% Diverflow VA8 (Basic): No active substance Packaging information: Professional use

Material Diverflow VB19 (Alpha): HDPE Diverflow VA8 (Basic): only bulk tranport

Size / content Diverflow VB19 (Alpha): 950L IBC, 200L, 20L

Other information -

Diverflow VA8 (Basic): only bulk

2.3 Overall conclusions identity The identity of the active substances and the biocidal product is sufficiently described. This application concerns a prolongation of the authorisation. The product has not changed. Data requirements None. 3

Physical and chemical properties

3.1 Physical and chemical properties of the active substance The list of endpoints below is taken from the IUCLID dossier. Melting point (state purity)

158 °C (IUCLID)


5


Boiling point (state purity) Temperature of decomposition Appearance (state purity) Relative density (state purity) Surface tension Vapour pressure (in Pa, state temperature) Henry’s law constant (in Pa·m3·mol-1)

Solubility in water (in g/l or mg/l, state temperature) Solubility in organic solvents (in g/l or mg/l, state temperature)

Partition co-efficient (log Pow) (state pH and temperature) Hydrolytic stability (DT50) (state pH and temperature) Dissociation constant UV/VIS absorption (max.) (if absorption >290 nm state ε at wavelength) Photostability (DT50) (aqueous, sunlight, state pH) Quantum yield of direct phototransformation in water at λ > 290 nm Photochemical oxidative degradation in air Flammability or Flashpoint Auto-flammability Oxidative properties Explosive properties

298 °C (estimation using MPBPWIN v 1.40) 211 °C (at circa 0.25 Atm, IUCLID) No data White solid, in pure form crystalline 1.4 g/ml (at 4-20°C, IUCLID) No data 4 mPa (at 25°C, estimation using MPBPWIN v 1.40) 11 mPa (at 25°C, IUCLID) 10-3 – 6 x10-6 (estimation using HenryWin v.3.10) 4 x 10-4 (calculated from vapour pressure 11 mPa and water solubility of 3.8 g/L) 3.8 g/L (at 25°C, estimation using WSKOW v 1.40) ca 2 g/L (at 20 °C, IUCLID)* Data from IUCLID (Temperature unknown): 350 g/L ethanol 330 g/L acetone 20 g/L chloroform 7 g/L benzene 17 g/L glycerol 12 g/L oil 2.24 (estimation using KOWWIN v.1.66) 2.25 (at 20°C, IUCLID, as neutral compound eg pH<2)** No data, according to IUCLID is hydrolysis not expected an important environmental fate process because it does not contain any hydrolysable groups. pKa 2.95 Strong absorption below 250 nm, and between 270 and 330 nm. No data, however it is known that salicylic acid is sensitive for degradation by (sun)light No data DT50 = 9.9 hr (estimation using AopWin v.1.90) Flashpoint: 157 °C (closed cup method, IUCLID) No data on flammability Ca 550°C (IUCLID) No oxidative properties (MSDS) Possibility of dust explosions with a lower limit of 30 g/m3 No data on explosive properties according to EEG method A.14, however on basis MSDS there are no explosive properties

*) the measurement of the water solubility in the IUCLID dossier is not reliable. The pH of the water is not buffered so after addition of salicylic acid the pH is decreasing, meaning that only the solubility at pH about 3 is determined. The solubility at pH 7 will be higher. The model calculation is for neutral compounds, so at pH 7, when salicylic acid is completely dissociated, the water solubility will be even higher than the calculated value. **) the value of the LogPow is pH dependent. In addition, no information on the method used for determination of the logPow is available. If the compound is surface active, which is unclear at this point, the value of the logPow may not be reliable.

3.2 Physical and chemical properties of the biocidal product Appearance Diverflow VB19 (Alpha): clear, light yellow liquid Diverflow VA8 (Basic): clear, colourless liquid Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic), 20070984 TVB

6


Explosive properties Oxidative properties Autoflammability Flashpoint pH 1% solution

Particle size distribution Surface tension Viscosity Relative density Storage stability/Shelf life/Packaging

Technical properties Physical and chemical compatibility

Diverflow VB19 (Alpha):not explosive Diverflow VA8 (Basic): not explosive Diverflow VB19 (Alpha): not oxidising Diverflow VA8 (Basic): not oxidising Diverflow VB19 (Alpha): not auto flammable Diverflow VA8 (Basic): not auto flammable Diverflow VB19 (Alpha): not highly flammable Diverflow VA8 (Basic): not highly flammable Diverflow VB19 (Alpha): pH1%=11.0 Diverflow VA8 (Basic): pH1%=1.5 Diverflow VB19 (Alpha): pH100%=12.3 Diverflow VA8 (Basic): pH100%<1 Total alkalinity Diverflow VB19 (Alpha)=1.0 Total acidity Diverflow VA8 (Basic)=46.5 Not applicable Not applicable Not applicable Diverflow VB19 (Alpha): 1.080 Diverflow VA8 (Basic): 1.65 2 years in HDPE at room temperature. Tested parameters were active substance content (only Alpha), sulphate content (only Basic), packaging, appearance, pH, density, alkalinity, viscosity and surface tension. All parameters remain within acceptable limits. Not applicable Not applicable

3.3 Overall conclusions physical and chemical properties The physical and chemical properties of the active substances and the biocidal product are sufficiently described by the available information. This application concerns a prolongation of the authorisation. The product has not changed. Supported shelf life of the product is 2 years in HDPE Data requirements None. 4 Analytical methods for detection and identification The list of endpoints below for salicylic acid is taken from the IUCLID dossier. 4.1 Analytical methods for the technical active substance Technical as (principle of method) No data Impurities in technical as (principle of method)

No detailed data

The analytical methods for salicylic acid and impurities in the technical material are part of the IUCLID dossier and therefore are acceptable. Technical salicylic acid can likely be analysed with common techniques, e.g. by HPLC. 4.2 Analytical methods for analysis of the biocidal product Preparation (principle of method) UV-VIS (295 nm) Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic), 20070984 TVB

7


4.3 Residue analytical methods Food/feed of plant origin (principle of method and LOQ for methods for monitoring purposes) Food/feed of animal origin (principle of method and LOQ for methods for monitoring purposes) Soil (principle of method and LOQ) Water (principle of method and LOQ)

Air (principle of method and LOQ) Body fluids and tissues (principle of method and LOQ)

No data, no method required

Not applicable

Not applicable Drinking water: LOQ ca 1 mg/L (HPLC-UV) Surface water: no data Literature search: Epa method: CE/LIF LOQ ca 0.1 µg/L, conformation with GCMS RIVM method: LCMSMS, LOQ 0.1 µg/L or lower. No data, not required Not required, non toxic compound

Based on the intended use of the product no residue analytical methods for food/feed of plant and animal origin are required. For monitoring the active substance in the environment methods are available for drinking and surface water. For air and soil no methods were provided. No exposure is expected regarding the intended use. As salicylic acid is a bulk chemical, sufficient information is available in public literature. 4.4 Overall conclusions methods of analysis The submitted analytical methods meet the requirements. This application concerns a prolongation of the authorisation. The product has not changed. Data requirements None. 5

Efficacy

The efficacy of Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) has not been changed, and therefore this assessment was not performed. 6

Human toxicology

Human health effects assessment active substance Salicylic acid A draft CA-report on salicylic acid is not yet available. The List of Endpoints below is based on the substance dossier submitted to the eCA The Netherlands. List of Endpoints Absorption, distribution, metabolism and excretion in mammals (Annex IIA, point 6.2) Rate and extent of oral absorption:

Salicylic acid is extensively absorbed. Absorption is pH dependent and absorption of salicylic acid increases at lower gastric pH values.


8


Rate and extent of dermal absorption:

Salicylic acid is absorbed through the skin but highly dependent on vehicle

Distribution:

Salicylic acid is well distributed with the highest concentrations found in serum, liver and kidney. The lowest amount is found in the brain.

Potential for accumulation:

Minimal. Salicylic acid is well metabolized and halflife is indicated at 15 hours in humans

Rate and extent of excretion:

Salicylic acid is primarily excreted in the urine as the glycine conjugate (salicyluric acid, 75%). Other metabolites in detected in the urine include two glucuronide conjugates and two oxidation products. In alkaline urine the free salicylate may be found at significant levels (30% of ingested substance) while in acid urine it is only found in negligible levels.

Toxicologically significant metabolite

Salicylic acid

Acute toxicity (Annex IIA, point 6.1) Rat LD50 oral

891 mg/kg bodyweight

Rabbit LD50 dermal

10000 mg/kg bodyweight

Rat LC50 inhalation

No reliable study available

Skin irritation

Non-irritant

Eye irritation

Corrosive

Skin sensitization (test method used and result)

Mouse Ear Swelling Test: Negative Human Maximization Test: Negative

Repeated dose toxicity (Annex IIA, point 6.3) Species/ target / critical effect

No repeated dose study available Subchronic (17 weeks): Rat/decrease in bodyweight gain and increase in liver/kidney weight Chronic (2 years): Rat/ decrease in bodyweight gain and increase in liver and kidney weight, gross pituitary lesions

Lowest relevant oral NOAEL / LOAEL

50 mg/kg bodyweight methyl salicylate (corresponding to 46 mg/kg bodyweight of salicylic acid)

Lowest relevant dermal NOAEL / LOAEL


Lowest relevant inhalation NOAEL / LOAEL


Genotoxicity (Annex IIA, point 6.6)

Not genotoxic in bacterial and mammalian mutagenicity assays or in a mammalian


9


chromosomal aberration assay.

Carcinogenicity (Annex IIA, point 6.4) Species/type of tumour

Human and animal studies

lowest dose with tumours

Animal studies do not indicate an increased incidence of tumors following exposure to any of the salicylates. An increase in tumors has also not been observed in humans following chronic use.

Reproductive toxicity (Annex IIA, point 6.8) Species/ Reproduction target / critical effect

Rat/No effects seen

Lowest relevant reproductive NOAEL / LOAEL

250 mg/kg bodyweight of methyl salicylate/no LOAEL established (=228 mg/kg bodyweight of salicylic acid)

Species/Developmental target / critical effect

Rat/malformations and reduction in viability*

Lowest relevant developmental NOAEL / LOAEL

50 /125 mg/kg bodyweight/day of acetylsalicylic acid (=39/98 mg/kg bodyweight/day of salicylic acid)

* The classification for developmental effect is currently under debate in the Risk Assessment Committee of ECHA.

Neurotoxicity / Delayed neurotoxicity (Annex IIIA, point VI.1) Species/ target/critical effect

Neurotoxicity study not available. No neurotoxic effects observed in other studies.

Lowest relevant developmental NOAEL / LOAEL.

Not established

Other toxicological studies (Annex IIIA, VI/XI) Endpoint waived

Medical data (Annex IIA, point 6.9) There are few adverse effects of salicylic acid

Summary (Annex IIA, point 6.10) Short/medium-term AEL

Rat, 17 week: 0.46 mg/kg (safety factor of 100)*

Long-term AEL

Rat, 2 year:


0.46 mg/kg (safety factor of 100)* 10


ADI (if residues in food or feed)

Residues are only expected to be present in very low amounts in foodstuffs. An acute reference dose (ARfD) has not been established due to the low acute toxicity of salicylic acid. An ADI was established based on the 2 year feeding study of methylsalicylate in dog and a safety factor of 100: ADI = 0.50 mg/kg bodyweight (=0.46 mg/kg bodyweight of salicylic acid) An ADI for methylsalicylic acid has also been established by the joint FAO/WHO Expert Committee on food additives and later adopted by the Council of Europe Committee of Experts on Flavouring Substances: ADI= 0-0.5 mg/kg bodyweight (=0-0.46 mg/kg bodyweight of salicylic acid)

Drinking water limit

-

* This corresponds to 27.6 mg/day for a 60 kg operator

Local effects Salicylic acid produces local effects after a single exposure (eye irritation), but these local effects are covered in the risk assessment/management by means of assignment of H- and P-statements. Salicylic acid does not produce local effects after repeated exposure. 6.1

Human exposure assessment active substance

6.1.1 General aspects Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) is a liquid formulation containing salicylic acid as active substance. The biocidal product concerns a disinfectant for food and feed areas (PT04). The area of application is as Cleaning In Place (CIP) disinfection of surfaces in the soft drink industry and in breweries. This application concerns a prolongation of the authorisation. Only the Dual CIP Diverflow VB19 (Alpha) contains 15% salicylic acid as active substance. It is intended to be mixed with the Diverflow VA8 (Basic) component consisting of strong acids (delivered via bulk transport). The maximum dosage is 0.25% Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) (generates an in-use concentration of 0.04% salicylic acid). The formulation Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) is intended for professional use. 6.1.2

Identification of main paths of professional exposure towards active substance from its use in biocidal product The product is only allowed to be used with appropriate dosing equipment in closed process systems. Therefore, the professional user can be respiratory and dermally exposed to salicylic acid during coupling/decoupling of transfer lines during automated dosing. The respiratory exposure to salicylic acid is expected to be negligible in view of the low the vapour pressure (4 x 10-3 Pa (estimated) / 11 x 10-3 Pa (at 25°C, IUCLID) and the low Henry’s law constant (10-3 – 6 x10-6 (estimated) / 4 x 10-4 (calculated from vapour pressure 11 mPa and water solubility of 3.8 g/L)). Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic), 20070984 TVB

11


As the Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) is used by professionals, oral exposure to salicylic acid is considered negligible. 6.1.3

Identification of main paths of non-professional exposure towards active substance from its use in biocidal product The formulation Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) is to be used by professionals only. 6.1.4 Indirect exposure as a result of use of the active substance in biocidal product According to the WG/GA the treated surfaces need to be rinsed for 5-10 minutes with drinking water until no salicylic acid is present in rinsing water. Therefore, no exposure to salicylic acid via soft drinks or beer due to the use of Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) is to be expected. Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) is to be used in closed process systems, therefore any bystander exposure can be excluded. 6.2

Human health effects assessment product

6.2.1 Toxicity of the formulated product No studies with Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) have been submitted and the classification and labelling of the formulation has been prepared based on the calculation method described in Annex I of Regulation 1272/2008/EC. 6.2.2 Data requirements formulated product No additional data requirements are identified. 6.3

Risk characterisation for human health

6.3.1 Professional users The exposure during mixing and loading operations has been calculated using the Mixing and Loading Model 7 (HEEG 2008, TNsG part 2 p.142 (corrected)) for liquids). The indicative dermal exposure is 1.01 mg/min (inside gloves). The indicative dermal exposure without PPE is recalculated from actual exposure inside gloves using a factor 100 for the use of gloves and protective clothing, and is equal to 101 mg/min. Respiratory exposure was not considered due to a very low vapour pressure of salicylic acid and the low Henry’s law constant (see 6.1.2) and the fact that no droplet formation is expected during mixing and loading operations. A duration of a single mixing and loading event is estimated to be 10 minutes per day. A dermal absorption of 25% is considered, as the concentrations of salicylic acid in the formulation is ˃5% (EFSA, Guidance on Dermal Absorption, 2012). During mixing and loading operations professional users will be exposed to the undiluted product.


12


Table T.1 Internal professional operator exposure mixing and loading to salicylic acid and risk assessment for the use of Dual CIP Diverflow VB19 (Alpha) Route Internal exposure Systemic AEL Risk-index2 (mg/day) 1 (mg/day) Mixing and loading3, no PPE Dermal 37.9 Respiratory negligible Mixing and loading3, with PPE Dermal 0.38 Respiratory negligible

27.6

1.37

27.6

0.01

1

Internal exposure is calculated with: 25% dermal absorption Risk index is derived by dividing the internal exposure by systemic AEL. 3 Calculations were based on: model 7, corrected for liquids. 4 For PPE the indicative value inside gloves is used. 2

On the basis of the above considerations, it can be concluded that the risk for the protected professional user (gloves) of Dual CIP Diverflow VB19 (Alpha) is acceptable. 6.3.2 Non-professional users, including the general public The formulation Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) is to be used by professionals only. 6.3.3 Indirect exposure as a result of use According to the WGGA the treated surfaces need to rinsed for 5-10 minutes with drinking water until no salicylic acid is present in rinsing water. Therefore, no exposure to salicylic acid via soft drinks or beer due to the use of Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) is to be expected. Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) is to be used in closed process systems, therefore any bystander exposure can be excluded. 6.3.4 Combined exposure Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) contains only one active substance and it is not described that it should be used in combination with other formulations. However, it is described that the component Diverflow VB19 (Alpha) should be mixed with the Diverflow VA8(Basic) component. This component of strong acids will have local effects, which will be covered by the use of PPE. Furthermore, the WGGA prescribes the use of a fully automated dosing system. Therefore, the risk of combination toxicology is expected to be negligible. 6.4

Overall conclusions for the aspect human health

Based on this risk assessment, it was concluded that no adverse health effects are expected for the protected (gloves) professional user after dermal and respiratory exposure to salicylic acid as a result of the application of Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic), when used in accordance to the WG/GA. Furthermore, when used according to the WG/GA, no adverse health effects are expected for the general public by indirect exposure to salicylic acid as a result of the application of Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic). 7

Environment

7.1 Introduction Authorisation is requested for the product Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) containing salicylic acid as active substance. The biocidal product concerns Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic), 20070984 TVB

13


a disinfectant for food and feed areas (PT04). The product is for professional use. The intended uses are described in Table E.1. Table E.1.

Intended uses, dosage, and use concentration of the active substance. Area of use envisaged Concentration Dosage Dosage active substance in product active product (g/L)* (L/day)* substance (kg/day)*

Cleaning In Place (CIP) disinfection of surfaces in the soft drink industry and in breweries, excluding milking parlour systems on farms, and kitchens in health care facilities (PT04)

162 (15% w/w)

2.5-119

0.405-19.2

*The efficacy of the product is determined by the combination of the active substance salicylic acid ( a weak acid) in the Diverflow VB 19 component and strong acids (which are not considered as active substances) in the Diverflow VA 8 component.

7.2 Product related studies The exposure assessment is based on data for the active substance. There are no fate or ecotoxicity data available for the product. The data for the active substance applied in the current risk assessment is presented in appendix I. 7.3

Environmental exposure assessment

7.3.1 Chemistry and/or metabolism Salicylic acid is a natural occurring substance and found in, for example, plants where it acts as a hormone to facilitate transpiration and ion uptake, and induces several changes in leaf anatomy. As a biocide, however, it changes the inner pH of cells, which eventually results in the cell’s dead. Under environmental pH conditions (5-9), salicylic acid immediately dissociates almost completely, loses a proton to water forming the salicylate anion, but further hydrolysis is not expected. Salicylic acid is classified as readily biodegradable. However, no information is available on degradation rates in water and soils. From the known degradation kinetics of salicylic acid (easily degradable) it is not expected that any relevant metabolite(s) (>10%) will persist. Under normal environmental conditions (pH >5), salicylic acid will predominantly occur (>99%) as salicylate. As the active substance is salicylic acid, this substance name is used in the environmental exposure and risk assessment. The active substance’s physical-chemical properties applied for the exposure assessment are summarised in appendix I. 7.3.2 Distribution in the environment Various phases in the life cycle of a product may cause emissions and environmental exposure. Significant release to the environment will therefore occur during the application of products holding the biocide. Table E.2 summarises the receiving environmental compartments that have been identified as potentially exposed during the use of the product for the different applications. Compartments indicated with a ‘Q’ will be qualitatively assessed only. Emissions from active substance production and product formulation are not part of the risk assessment. The routes of entry into the environment are explained in more detail in the next sections.


14


Table E.2. Foreseeable routes of entry into the environment on the basis of the intended use. Main scenario Environmental compartments exposed Cleaning In Place (CIP) disinfection of surfaces in the soft drink industry and in breweries, excluding milking parlour systems on farms, and kitchens in health care facilities (PT04)

STP

Freshwater1

Saltwater1

Soil2,3

Air

++

+

-

-

- (Q)

++ Compartment directly exposed, + Compartment indirectly exposed, (Q) Qualitative assessment, depending on 1 2 3 application, Including sediment, Including groundwater, and soil invertebrates and arthropods, In the Netherlands, surplus sludge of public STPs is not applied for fertilization and soil improvement of agricultural soil. Therefore, exposure of soil and groundwater via STP surplus sludge application is not part of the risk assessment.

After disinfection, waste water holding residues of the product are predominantly discharged to the sewer and via the sewage treatment plant (STP) eventually end up in surface water. In The Netherlands, sewage sludge is utilized for energy recovery, not as a soil fertilizer. Therefore soils are not exposed to sewage sludge. Considering that the product is used in installations, tanks, and pipes (CIP), emission to air is assumed negligible. 7.3.3

Predicted environment concentration calculations

7.3.3.1 General Predicted Environmental Concentrations (PECs) were calculated according to relevant exposure scenario documents (ESDs, release to the environment), the Technical Guidance Document (distribution in the environment), and the model SimpleTreat (concentrations for micro-organisms in a STP and the STP’s effluent) by using the default values for parameters, unless otherwise noted. Release of active substances during the waste phase of the end-products is not assessed either, because it is assumed that end-products to which the active substances are added are disposed as solid waste and usually incinerated. Possible pH effects on the environment were not considered, because the STP and receiving compartments are expected to have sufficient buffering. The assessment was made for the highest dose only. The risk assessment is based on the active substance’s physical-chemical properties as listed in appendix I and the concentrations as listed in Table E.1. 7.4 Environmental effect assessment Risk assessment is based on Predicted No-Effect Concentrations (PNECs) for the different compartments which are derived from ecotoxicity data and applying assessment factors. The assessment factor depends on the type of test performed (acute or chronic), the toxicological endpoint (effect concentrations (ECs), no-observed effect concentrations (NOECs), etc), and the number of data and is determined according to the Technical Guidance document (version 2003 chapter 3). The PNECs based on the ecotoxicological data applied for the current risk assessment are presented in Table E.3. Table E.3. PNEC STP fresh water

Predicted no-effect concentrations for salicylic acid Value unit AF Data available at Ctgb 100

mg/L

10

EC50 respiration inhibition study

0.198

mg/L

50

Chronic data for 3 species, representing 2 trophic levels


15


Note that data on sediment organisms is not available and therefore have to be derived from aquatic data by applying equilibrium partitioning. However, PECsediment is also derived by using equilibrium partitioning from PECfreshwater and therefore the ratio PEC:PNEC for freshwater covers that of sediment as well. Because the logarithmic octanol-water partition coefficient (log Kow) is below 3 (2.26), the salicylic acid has a low potential for bioaccumulation. PNECs for birds and mammals are therefore not presented. 7.5 Risk characterisation for the environment For each relevant compartment, PECs are divided by PNECs. Risks are considered unacceptable when PEC/PNEC >1. 7.5.1

Aquatic compartment (incl. sediment) and STP

7.5.1.1 Water and sediment organisms and micro -organisms in the STP The risk characterisation for the aquatic compartment (freshwater and sediment) indirectly exposed via a STP are presented in Table E.4 Table E.4.

PEC and PEC/PNEC ratios for micro-organisms in the STP and freshwater indirectly exposed due to disinfection of CIP installations STP Fresh water PEC (mg/L)

PNEC/PNEC

PEC (mg/L)1,2

PNEC/PNEC

Cleaning In Place (CIP) disinfection of surfaces in the soft drink industry and in breweries, excluding milking parlour systems on farms, and kitchens in health care facilities (PT04) 1.21 1 2

0.012

0.121

0.609

removal of the active substance(s) by sorption onto suspended matter is included. the presented risk ratios are also valid for sediment (see section 7.4).

The application of salicylic acid to disinfect CIP installations does not result in unacceptable risks as PEC:PNEC<1 in both freshwater and sediments.. The standards for the environment are therefore met. Direct exposure to estuarine and mar ine water Because effluent from STPs receiving waste water from the disinfection of CIP installations may be emitted to estuarine and marine water, direct exposure to the marine environment is likely. In general, the PNECmarine will be 10 times higher as marine assessment factors are 10 times higher than for fresh water (TGD). However, the PEC will be 10 times lower as the dilution factor is 100 instead of 10. Risk ratios are thus expected to be similar, and therefore risk assessment for fresh water also covers risks for the marine environment. Because the standards for fresh water are met, the standards for the marine environment are also met. 7.5.1.2 Monitoring data (surface water) Dutch water boards have a well-established programme for monitoring pesticide contamination of surface waters for which the results are publicly available on-line (www. bestrijdingsmiddelenatlas.nl). Here, monitoring data are processed in a graphic format aiming to provide an insight into measured pesticide contamination of Dutch surface waters against environmental standards. The Pesticide Atlas was used to evaluate measured concentrations of pesticides in Dutch surface water, but no data are available regarding the presence of salicylic acid in Dutch surface water.


16


7.5.1.3 Surface water intended for the abstraction of drinking water Biocidal products with the active substance salicylic acid have been on the market for more than three years. The existing active substances are not included in the list of substances of concern due to its presence in surface water at drinking water abstraction points as established by VEWIN/Ctgb (2014). In addition, the active substance is not included in the recommended list of biocides to be monitored for drinking water from surface water (RIVM, 2010). Considering this the Ctgb concludes that there are in this case insufficient indications for concern about the consequences of this product for surface water from which drinking water is produced, when used in compliance with the directions for use. Thus the standards for surface water destined for the production of drinking water are met. 7.5.2

Terrestrial compartment

7.5.2.1 Soi l organisms For the intended use of the product, emission of the active substance to soil is not expected. Direct exposure is negligible for bees as the product is used indoors. The exposure of non-target arthropods and soil organisms (including bees) to the active substance is therefore deemed negligible. Hence, the risk for soil organisms and non- target arthropods (including bees) is considered acceptable for the intended uses. 7.5.2.2 Non-target arthropods (including bees) The risk assessment to arthropods is considered to be similar to soil organisms due to their direct contact with soils. The standards for soil arthropods are therefore met. Because the active substance is expected to have a non systemic mode of action, secondary exposure of bees through pollen is considered negligible. Hence, the risk for bees is considered acceptable for the active substance. 7.5.2.3 Groundwater Assessment of the drinking water criterion defines that the concentration of the active substance and the relevant metabolites in groundwater for the preparation of drinking water needs to be < 0.1µg/L. In The Netherlands, the application of sewage sludge as a soil fertilizer is not foreseen. Therefore, no biocides are discharged to the soil compartment along with sewage sludge. Direct emission to soils is not foreseen as well as residues are predominantly discharged to the sewer. Therefore, application of the product according to the instructions of use will not result in unacceptable risks for the groundwater compartment. 7.5.2.4 Persistence in soil The actives substances’ half lives in soils (see appendix I) does not exceed the criteria for persistence in soils (180 days). The standard for persistence in soils is therefore met. 7.5.3

Non compartment specific effects relevant to the food chain

7.5.3.1 Bioconcentration As the log Kow of the active substance is < 3 (see appendix I) and the substance is not highly adsorptive (Koc <20000 L/kg in sediment and/or 50000 L/kg in soils), bioconcentration is not expected according to the trigger values presented in the TGD. The risk for bioconcentration in the proposed uses is therefore considered not relevant. The standards for bioconcentration are met and no further assessment of secondary poisoning is deemed necessary. 7.5.3.2 Primary and secondary poisoning of birds and mammals The low BCF (see above) indicates that the risk for birds and mammals is low regarding secondary poisoning. Hence the products meet the standards for the risk to birds and mammals. Primary poisoning is not expected for the intended uses.


17


7.5.4 Atmosphere Criteria for the examination of environmental risks to air are not specified in the form of a numerical standard. The assessment of potential impacts on air quality is aimed to minimize the risk for stratospheric ozone depletion. There are no indications that salicylic acid contributes to depletion of the ozone layer as the compound is not listed as ‘controlled substance’ listed in Annex I of Regulation (EC) No 1005/2009 of the European Parliament. Moreover, AOPwin calculates for the active substance a half life of 29.5 hours in air (OH timeframe 24 hrs/day, 0.5×106 OH radicals/cm3). The calculated half live is below the trigger of 2 days, which is used as cut off value to identify chemicals that could be of potential concern for long range transport through the atmosphere. The environmental risk to air is therefore considered acceptable. 7.6 Measures to protect the environment (risk mitigation measures) The applicant did not include any risk mitigation measures for the environment in the draft WG/GA and PGB-PUB. Additional risk mitigation measures are not required, considering that risks to the environment are acceptable for the intended uses. 7.7 Overall conclusion for the aspect Environment An authorisation of a biocide in the Netherlands is only possible when the risks related to the product application are acceptable. When used in accordance with the legal Instructions for Use (WG/GA), Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) complies with the environmental standards and will not cause unacceptable effects to the environment. No risk mitigation measures are necessary. 7.8 Data requirements There are no additional data required. 8 Conclusion The applicant has proven that Dual CIP Diverflow VB19 (Alpha)/ Diverflow VA8 (Basic) under the proposed Legal Conditions for Use and the Directions for Use (WG/GA), is sufficiently effective and that no unacceptable risk is expected to human health, the person who uses the product and the environment (Art. 121 jo art. 49 first paragraph Dutch 2007 Plant Protection Products and Biocides Act). 9 Classification and labelling Based on the profile of the substance, the provided toxicology of the preparation, the characteristics of the co-formulants, the method of application and the risk assessment for the operator, as mentioned above, the following labeling of the preparation is proposed: Diverflow VB19 (Alpha): The identity of all substances in the mixture that contribute to the classification of the mixture *: ......... Pictogram: GHS07 Signal word: Warning ......... ......... H-statements: H290 May be corrosive to metals. H315 Causes skin irritation. H319 Causes serious eye irritation. P-statements: P280 Wear protective gloves.


18


Supplemental Hazard information:

-

Child-resistant fastening obligatory? Tactile warning of danger obligatory?

Not applicable Not applicable

Explanation: Pictogram: H-statements:

H290 is assigned. Due to the absence of test data, the product is classified as corrosive to metals based on pH. P-statements: Based on the risk assessment gloves are prescribed for the professional operator. Other: * according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b) Diverflow VA8 (Basic): The identity of all substances in the mixture that contribute to the classification of the mixture *: zwavelzuur Pictogram: GHS05 Signal word: Danger ......... ......... H-statements: H290 May be corrosive to metals. H314 Causes severe skin burns and eye damage. P-statements: P260 Do not breathe dust/fume/gas/mist/vapours/spray. P280 Wear protective gloves/protective clothing/eye protection/face protection. P303+P361+P353 IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower. P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310 Immediately call a POISON CENTER/doctor/… Supplemental Hazard information: Child-resistant fastening obligatory? Tactile warning of danger obligatory?

Not applicable Not applicable

Explanation: Pictogram: H-statements:

H290 is assigned. Due to the absence of test data, the product is classified as corrosive to metals based on pH. P-statements: Other: * according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)


19


10 References Bakker, J. Biociden in oppervlaktewater voor drinkwaterproductie, National Institute of Public Health and the Environment, RIVM report 601712007, 2010, Bilthoven, The Netherlands. Database with monitoring data from pesticides in surface water obtained from regional waterboards. http://www.bestrijdingsmiddelenatlas.nl Emission Scenario Document for Product Type 4: Disinfectants used in food and feed areas, JRC Scientific and Technical Reports, Report nr. EUR 25117 EN, Publications Office of the European Union, Luxembourg, 2011 Lijst met probleemstoffen voor de bereiding van drinkwater uit oppervlaktewater, VEWIN, 2014, http://www.vewin.nl/probleemstoffen Struijs J. SimpleTreat 3.0: a model to predict the distribution and elimination of chemicals by sewage treatment plants. National Institute for Human Health and the Environment. RIVM report 719101025, Bilthoven, The Netherlands, 1996. Regulation (EC) No 1005/2009 of the European Parliament and the Council of 16 September 2009 on substances that deplete the ozone layer. Technical guidance document on risk assessment. Part II. European Commission Joint Research Centre, EUR 20418 EN/2, 2003, Ispra, Italy.


20


Appendix I. Input parameters for modelling Value molecular weight (g/mole)

138.12

vapour pressure at test temperature (Pa)

0.011

test temperature vapour pressure (°C)

20

solubility at test temperature (mg/L)

500

test temperature solubility (°C)

20

Henry constant (Pa m³/ mol)

-

test temperature Henry’s constant (°C)

-

octanol-water partition coefficient (L/kg)

182

organic carbon-water partition coefficient (L/kg)

179.5

organic matter-water partition coefficient (L/kg)

105.6

half-life for biodegradation in fresh water at 12°C (days)

-

half-life for biodegradation in sediment at 12°C (days)

-

Remarks

this value is for the non-dissociated molecule (pH < 3). At higher pH, the active substance will be present as the salicylate anion for which a log Pow is not needed.

Derived from Koc.

half-life for biodegradation in soil at 12°C (days)

30

Default value for readily biodegradable compounds that are not mobile in soils.

half-life for leaching from soils at 12°C (days)

-

rate constant for biodegradation in STP (/d)

1

Default value for readily biodegradable compounds

29.5

AOPWIN-estimation (24hr day, 0.5×10 OH/cm³)

6

half-life in air (hrs)


21

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

Recommend Documents